Re: Investigate into the Leadership of the Food and Drugs Authority

09 October 2013

Dear Mr. President

PETITION REQUESTING AN INVESTIGATION INTO THE DRUG REGULATORY ACTIVITIES OF THE FOOD AND DRUGS AUTHORITY GHANA

My name is Kwame SarpongAsiedu of 366 Straight Road Lexden, Colchester, England; a registered Pharmacist of 14 years post-registration experience and a former lecturer in the Department of Pharmaceutical Chemistry, Faculty of Pharmacy, KNUST. I am a member of the Royal Pharmaceutical Society of Great Britain and Northern Ireland, Member of the Pharmaceutical Society of Ghana, Member of the Institute of Pharmacy Management UK and Institute of Directors of the United Kingdom.

I left Ghana abruptly in 2002 due to certain circumstances surrounding the market entry of medicines onto the Ghanaian market and, I regret to say from what I read and am informed about, the situation has not changed over the past 11 years. I am, thus, petitioning your august office for an investigation into the leadership of the Food and Drugs Authority about matters I will shortly outline with reasons.

In just over six months, the Food and Drugs Authority (FDA) in Ghana has had to warn the general public about incidences of unwholesome (fake, unlicensed, unregistered) medicines in circulation. On the face of it, this should be seen as a very prudent act by the sole regulator of medicines in Ghana. Unfortunately the frequency of these reports points to a potential regulatory failure on the FDA’s part.

The first major report involved Osons Chemist, Roxin Ghana Limited and a few other importers in February 2013. At the start of that, I wondered how the medicines had gained market entry in the first place as the entry of medicines is a highly regulated activity.

The FDA informed the general public that they had involved the BNI and CID to help unravel the circumstances surrounding the incident. I stand to be corrected, but till this day there is no information on the outcome of those investigations available to the general public.

Over the last few weeks, the story of Tobinco Pharmaceuticals having in its custody and distributing across Ghana over 100 medicines that contravene the laws of Ghana, and can all be classified as unwholesome, has been worrying.

Mr. President, as you are hopefully aware, the Food and Drugs Act stipulates the FDA to have provisions in place for the importation of pharmaceuticals into Ghana. These provisions are aimed at ensuring the integrity of Ghana’s drug delivery system, ensuring drugs available to the average Ghanaian are safe, and minimizing drug treatment failure due to unwholesome medicines and ensuring value for money for the NHIS. As part of these provisions, the FDA issues clearance certification documents before any medicines can be cleared at any port of entry in Ghana. This certification is signed by an official of the FDA and the medicine consignment needs to be inspected by officials of the FDA at the port of entry.

If this is the process, then it begs the question: how could Tobinco clear all these products without FDA involvement? It seems to me that there was some level of connivance with regulatory officials to clear these medicines in the first place.

Even more worrying is the FDA’s claim in its statement that some of these medicines found their way into hospitals in Ghana. My worry stems from the fact that for a pharmaceutical company to tender for supply of medicines to the Ghana Health Service they need to provide evidence of FDA certification.

This: points to the fact that Tobinco may have in their procession certification documents for the said medicines and thus were able to tender. In my view, it needs to be established the authenticity or otherwise of these certification documents and if found to be authentic, the identification of the official or officials who authorized these documents for otherwise unwholesome medicines.

The Food and Drugs Act also stipulates that where a drug, cosmetic, device or chemical substances is imported as a finished product, an application for registration of the drug shall be accompanied by a quality assurance certificate issued by the competent drug controlling authority of the exporting country.

It is a worry for the FDA Chief Executive to inform Ghanaians that the anti-malarial medicine for children -Gsunate Plus - a suppository, which is manufactured in India by BLISS GVS Pharmaceutical Limited was imported into Ghana without any clinical data and that the product is not even licensed in India where it is manufactured for the treatment of malaria.

A clear breach of the Food and Drugs Act.Following this breach the FDA CEO informs Ghanaians that he advised the importer (Tobinco) to quarantine the unwholesome medicines an action that the regulator should have carried out. The FDA also from that statement did not indicate checking with the importer that the directive to quarantine had been carried out until they found the said Gsunate Plus on the market; a case of negligence that put innocent Ghanaian children at risk.

The final straw, Mr. President, is the publication that there are unregistered condoms on the market imported by the same Tobinco. What does this auger for the fight against HIV, other sexually transmitted diseases and unwanted pregnancies?

I will conclude by saying Ghana is a signatory to the World Health Organization (WHO) conventions, one of which governs the movement of drugs in international commerce. This WHO document specifies a number of steps that need to be followed when drugs are imported from one country to the other most of which are captured by the Food and Drugs Act but are clearly not being adhered to.

It is clear from the above that there seems to be systemic failings in the regulation of medicines by the FDA and in my humble view leadership failures, as the press releases seem to give the impression that the CEO is trying to shift the blame onto the importers solely.

It also suggests that, as a result of these failings, importers are abusing the system with impunity. I agree that the importers may have broken the law and need to be dealt with severely. However, the responsibility for this level of regulatory failure must rest solely with the leadership of the medicines regulator: the FDA. It surprises me Mr. President that the Pharmaceutical Society of Ghana (PSG) till date has not made any public pronouncement regarding such a serious issue. I think the silence is palpable hence my coming to you.

Unfortunately, Mr. President, medicines are not chocolates. The same principles of market forces do not apply and such failings cannot and should not be accepted. Malaria, for one, is a major killer in Ghana and has serious impact on sickness and national productivity. The last thing the world will want is resistance to antimalarials caused by such a level of possible regulatory incompetence, connivance or negligence of duty.

In a country where there is little statistics on mortality and/or morbidity due to drug treatment failure, no one can tell if anyone has died or had serious complications due to the use of any of these unwholesome medicines as this could make the actions of the importers and regulators potential manslaughter.

I trust that you will act as part of your quest to rid Ghana of corruption, negligence of duty and possible incompetence.

I will humbly suggest that the regulatory investigation is started from the very top to ascertain whether these systemic failings are an indication of poor leadership practice.